Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Tuesday, May 08, 2007

Stealth Health Policy Advocacy for Conflicted FDA Advisory Panels

Here we go again. As I write this, the US Senate is getting ready to consider whether to tighten restrictions on conflicts of interest affecting the US Food and Drug Administration's advisory panels. And last Friday, our own Providence Journal featured another op-ed warning of dire consequences of keeping conflicts member off these panels. This one, entitled "Mania for New Rules Imperils Health Care," was by Peter J Pitts, President of the Center for Medicine in the Public Interest.

The Arguments and My Responses

Restricting conflicted board members would set back science immeasurably.

What Pitts wrote was

Imagine if the scientific community had ignored Louis Pasteur’s research on bacteria and fermentation simply because he had received funding from the wine industry. Science would have been set back immeasurably....

This is a straw man argument. The new FDA regulations are about conflicts of interest affecting panels that help advise the FDA about making decisions about approval or disapproval of drugs or devices. They do not affect funding of scientific research, and particularly not basic (as opposed to clinical) research. They would certainly not make the scientific community ignore basic research that was commercially funded.

Note that Pitts reprised this argument later in his article.

The next time you go to the pharmacy and pick up a potentially life-saving drug, ask yourself if you really care who funded the research that led to its development.

Again, the issue is not about the funding of either basic or clinical research. (And as an aside, the argument leaves the impression that most drugs are "life-saving." It would be nice if that were true, but truly life-saving drugs are few and far between.)

Paying an expert to be a consultant should not influence his opinions

What Pitts wrote was

The FDA’s new rule is too sweeping, as it groups together experts who receive consulting fees and research funding with those who have a direct economic stake in a drug’s success.

This is a mistake. Pharmaceutical companies pour billions of dollars each year into exploring new drugs — cancer-fighting treatments, Alzheimer’s medications, cholesterol-lowering statins.

Sure, these corporations seek to profit. But are the scientists who conduct research on their behalf inherently predisposed to support their work?

This is a straw man argument. I don't think anyone said that academics who receive grant funding from pharmaceutical companies are "inherently" predisposed to support the companies' products. But they may well tend to avoid criticizing the company whose money allows their academic careers to flourish. Furthermore, what about academic who are paid personally to consult? They may be even less inclined to avoid such criticism. There is evidence that even receiving a small gift makes one think more favorably about the giver. Common sense suggests that getting a five-figure consulting fee would make one think even more favorably about the provider of the fee.

Existing laws and guidelines are sufficient to deal with conflicts of interest

What Pitts first wrote was

What’s more, when it comes to the sale of pharmaceuticals, the U.S. Department of Justice strictly enforces fraud, abuse and anti-kickback laws.

This is even more obviously a straw man argument. The issue is not how drugs are marketed. The issue is how the FDA makes decisions about which drugs can be marketed. The laws mentioned by Pitts are irrelevant to the FDA advisory board process.

And Pitts then wrote,

Plus, the leading drug manufacturers already adhere to voluntary marketing guidelines that prevent unethical relationships from arising in the first place. For example, the guidelines specify that gifts to physicians must support a medical practice, and shouldn’t exceed $100. Further, the guidelines stipulate that all entertainment — including tickets to sporting events — is inappropriate.

This is yet another straw man argument. The issue is not gifts given to physicians to help market drugs (although there is, as noted above, an argument that such gifts do affect physicians' decisions.) The issue is how the FDA makes decisions about which drugs can be marketed. The guidelines mentioned above are also irrelevant to the FDA advisory process. (And by the way, since they are voluntary guidelines, there is nothing compelling pharmaceutical companies to obey them.)

Arguments Made on Whose Behalf?

So, in summary, Pitts paean to conflicted FDA advisory board members amounted to a series of straw man arguments, interspersed with exaggerations about "life-saving" drugs and "miracle cures." This is the third opinion piece we have found whose arguments in favor of conflicts of interest seemed to be largely based on logical fallacies.

As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view. One would suspect that this may have influenced how he wrote his op-ed.

So Pitts' op-ed is our third recent example of an apologia for conflicts of interest affecting FDA advisory panels in a major media outlet which was written by someone who was conflicted by important ties to the pharmaceutical industry, but who obscured such ties. (See our previous posts about one example here and another here and here.)

These seem to be examples of stealth health policy advocacy (a cousin to stealth marketing and stealth lobbying).

We have argued before that patients and physicians need to be extremely skeptical about clinical evidence that may be disseminated as part of stealth marketing efforts.

Policy makers, physicians, and the public now also must be extremely skeptical about policy advocacy that may be disseminated as part of stealth health policy campaigns.

I am sounding like a broken record (anyone remember what that means), but...

If the pharmaceutical industry seeks to build trust among patients and physicians, it should at not hide the affiliations of its spokespeople. I am still waiting to see if any individuals without any relevant conflicts will stand up to argue the harmlessness of major conflicts of interest of FDA advisory panel members.

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